Novartis H1N1 Vaccine in Pregnant Women

Inclusion Criteria

Pregnant women:

• Pregnant female between the ages of 18 and 39 years, inclusive.
• Is from 14 weeks/0 days through 33 weeks/6 days of gestation.
• Had at least one prenatal visit during which pregnancy was confirmed.
• Is in good health, as determined by vital signs (heart rate less than or equal to 100 beats per minute; blood pressure: systolic less than or equal to 140 mm Hg; diastolic less than or equal to 90 mm Hg; oral temperature less than or equal to 100 degrees Fahrenheit), medical history to ensure any existing medical diagnoses or conditions are stable and not considered clinically significant, and targeted physical examination based on medical history.
• Receipt of the 2009-2010 seasonal influenza vaccine no less than two weeks prior to enrollment in this study.
• Intend to be available through 6 months following receipt of H1N1 vaccine.
• Able to understand and comply with planned study procedures.
• Provides written informed consent prior to initiation of any study procedures.
• Agrees to sign medical release for herself and her infant(s) to allow study staff to gather pregnancy outcome data, if needed per clinical site policy.

Non-pregnant women:

• Female between the ages of 18-39 years, inclusive.
• For the 30 days prior to enrollment through 30 days following receipt of H1N1 vaccine must fulfill one of the following: (i) she is not able to bear children because she has been surgically sterilized (tubal ligation or hysterectomy) for at least one year or is at least 1 year post-menopausal or (ii) she agrees to practice effective methods of contraception including, but not limited to, abstinence, barrier methods (such as a condom or diaphragm) used with a spermicide, birth control pills, patches or hormonal shots or hormonal implants, NuvaRing and IUDs (intrauterine devices).
• For a female subject of childbearing potential, must have a negative pregnancy test (urine or serum) within 24 hours prior to vaccination.
• Is in good health, as determined by vital signs, medical history to ensure any existing medical diagnoses or conditions are stable and not considered clinically significant, and targeted physical examination based on medical history (if indicated). A stable chronic medical condition is defined as no change in prescription medication, dose, or frequency of medication in the last 3 months and health outcomes of the specific disease are considered to be within acceptable limits in the last 6 months. Any change that is due to change of health care provider, insurance company etc, or that is done for financial reasons, as long as in the same class of medication will not be considered a violation of this inclusion criterion. Any change in prescription medication due to improvement of a disease outcome will not be considered a violation of this inclusion criterion.
• Receipt of the 2009-2010 seasonal influenza vaccine no less than two weeks prior to enrollment in this study
• Intend to be available for a follow-up visit and phone call access through 6 months following receipt of H1N1 vaccine.
• Able to understand and comply with planned study procedures.
• Provides written informed consent prior to initiation of any study procedures.

Exclusion Criteria

Pregnant women:

• Has a known allergy or hypersensitivity to eggs or other components in the vaccines (these may include, but are not limited to: polymyxin and neomycin).
• Has a history of severe reactions following previous immunization with influenza virus vaccines.
• Has participated in a novel influenza H1N1 2009 vaccine study in the past 2 years, has received a H1N1 2009 vaccine or has history of novel influenza H1N1 2009 infection evaluated by a healthcare professional prior to enrollment.
• Has received any other live licensed vaccines within 4 weeks or inactivated licensed vaccines within 2 weeks prior to vaccination in this study or plan receipt of such vaccines within 21 days following vaccination. Measles, mumps, and rub